This patent is directed to systems and methods for use with drug delivery devices relating to control of the drug delivery devices and communication of information obtained from the drug delivery devices.
Drugs can be administered through the use of drug delivery devices, such as autoinjectors or on-body injectors or infusers. These devices may replace older delivery systems using the combination of a syringe and a vial of the drug or medicament, or a pre-filled syringe. Autoinjectors and on-body injectors may be used to automate the injection and delivery or administration process, thereby simplifying the process for certain patient groups or sub-groups for which use of the syringe/vial combination or pre-filled syringe systems would be disadvantageous, whether because of physiological or psychological impediments.
Even with the use of drug delivery devices, such as autoinjectors, patients may experience challenges during the initial use of the drug delivery device after they have been prescribed a drug that is delivered or administered through the use of a drug delivery device. For example, the user may be uncertain whether the medication inside the drug delivery device is the medication prescribed for them. Additionally, the user may be uncertain whether the medication has expired. Further, the user may be uncertain whether the injection should be delayed after a drug delivery device has been removed from cold storage, such as in a refrigerator, and if the injection should be delayed, how long it should be delayed. The user may also be uncertain if the actions and their sequence correctly operate the drug delivery device. Even if the correct actions are performed in the correct sequence, the user may be uncertain the drug has been completely delivered, such that the injection is complete.
Other patients may experience challenges in being adherent or compliant with the treatment regimen. For example, certain patients may not perform the injections according to the treatment regimen, having forgotten to perform the injection at all. Other patients may perform the injections, but then be unable to remember whether they performed the injections because they become distracted before they are able to record that they did so. Some patients may elect not to perform the injections because of misunderstandings or miscommunications of when or how the medication will affect the patient's disease or symptoms, especially where the effects are not felt by the patient until a considerable portion of the treatment regimen has been performed. Some patients may require support and/or encouragement from others (healthcare provider, caregiver, family member, etc.), which support and/or encouragement cannot be provided because the people that would provide that support and/or encouragement do not know if the patient has performed the treatment or if the treatment regimen has been followed correctly.
In addition, the condition and use of drug delivery devices is of importance to other parties, such as drug device manufacturers, pharmacies, health care providers and insurers. For instance, information regarding the condition of the drug delivery device along the supply chain may be relevant to whether the drug delivery device will be in good working order when it arrives for use with the patient. Information regarding the location of the drug delivery device along the supply chain may be relevant to the manufacturer and the pharmacy to ensure that adequate supplies are available for the pharmacy to delivery to the user. The compliance information mentioned above may be important to the healthcare providers and insurers, as well as to the patient, because compliance with a therapy regimen may have a direct impact on the success of the therapy.
As set forth in more detail below, the present disclosure sets forth an drug delivery system embodying advantageous alternatives to existing drug delivery devices and that may address one or more of the challenges or needs mentioned above.